CN112566942A - 用于制造抗体-药物缀合物的有效方法 - Google Patents

用于制造抗体-药物缀合物的有效方法 Download PDF

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Publication number
CN112566942A
CN112566942A CN201980049551.8A CN201980049551A CN112566942A CN 112566942 A CN112566942 A CN 112566942A CN 201980049551 A CN201980049551 A CN 201980049551A CN 112566942 A CN112566942 A CN 112566942A
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antibody
production method
amino acid
buffer solution
acid sequence
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CN201980049551.8A
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山口达也
樱谷宪司
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Daiichi Sankyo Co Ltd
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Daiichi Sankyo Co Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
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    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47Quinolines; Isoquinolines
    • A61K31/4738Quinolines; Isoquinolines ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/4745Quinolines; Isoquinolines ortho- or peri-condensed with heterocyclic ring systems condensed with ring systems having nitrogen as a ring hetero atom, e.g. phenantrolines
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    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
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    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
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    • A61K47/68Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
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    • A61K47/51Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • A61K47/6801Drug-antibody or immunoglobulin conjugates defined by the pharmacologically or therapeutically active agent
    • A61K47/6803Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates
    • A61K47/68037Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates the drug being a camptothecin [CPT] or derivatives
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    • A61K47/51Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • A61K47/6835Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site
    • A61K47/6851Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site the antibody targeting a determinant of a tumour cell
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    • A61K47/50Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • A61K47/6835Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site
    • A61K47/6851Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site the antibody targeting a determinant of a tumour cell
    • A61K47/6855Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site the antibody targeting a determinant of a tumour cell the tumour determinant being from breast cancer cell
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    • A61K47/50Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
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    • A61K47/6889Conjugates wherein the antibody being the modifying agent and wherein the linker, binder or spacer confers particular properties to the conjugates, e.g. peptidic enzyme-labile linkers or acid-labile linkers, providing for an acid-labile immuno conjugate wherein the drug may be released from its antibody conjugated part in an acidic, e.g. tumoural or environment
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    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
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    • C07K2317/00Immunoglobulins specific features
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    • C07K2317/55Fab or Fab'

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  • Genetics & Genomics (AREA)
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  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Inorganic Chemistry (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
CN201980049551.8A 2018-07-25 2019-07-24 用于制造抗体-药物缀合物的有效方法 Pending CN112566942A (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
JP2018-139633 2018-07-25
JP2018139633 2018-07-25
PCT/JP2019/028949 WO2020022363A1 (ja) 2018-07-25 2019-07-24 抗体-薬物コンジュゲートの効果的な製造方法

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CN112566942A true CN112566942A (zh) 2021-03-26

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US (1) US20210283269A1 (https=)
EP (1) EP3828206A4 (https=)
JP (2) JPWO2020022363A1 (https=)
KR (1) KR20210038904A (https=)
CN (1) CN112566942A (https=)
AU (1) AU2019311557A1 (https=)
BR (1) BR112021001194A2 (https=)
CA (1) CA3107417C (https=)
IL (1) IL280295B2 (https=)
SG (1) SG11202100653YA (https=)
TW (2) TWI847992B (https=)
WO (1) WO2020022363A1 (https=)

Cited By (8)

* Cited by examiner, † Cited by third party
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CN116135232A (zh) * 2021-11-17 2023-05-19 石药集团巨石生物制药有限公司 抗体-药物偶联物及其用途
WO2024041587A1 (zh) * 2022-08-25 2024-02-29 启德医药科技(苏州)有限公司 抗体偶联药物的药物组合物
WO2024109840A1 (zh) * 2022-11-22 2024-05-30 康诺亚生物医药科技(成都)有限公司 稠环类化合物及其偶联物和用途
WO2024222662A1 (zh) * 2023-04-23 2024-10-31 石药集团巨石生物制药有限公司 一种抗体偶联药物的用途
WO2024235274A1 (zh) * 2023-05-16 2024-11-21 石药集团巨石生物制药有限公司 一种抗体药物偶联物的药物组合物
TWI862982B (zh) * 2021-09-15 2024-11-21 日商第一三共股份有限公司 抗體–藥物結合物之用途
WO2025021118A1 (zh) * 2023-07-25 2025-01-30 海南先声再明医药股份有限公司 配体-药物偶联物及其偶联连接子
WO2025067306A1 (zh) * 2023-09-26 2025-04-03 信达生物制药(苏州)有限公司 靶向her3的抗体-药物偶联物

Families Citing this family (16)

* Cited by examiner, † Cited by third party
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AU2018320470B2 (en) * 2017-08-23 2025-04-24 Daiichi Sankyo Company, Limited Antibody-drug conjugate preparation and lyophilization for same
CN115103858B (zh) * 2020-03-25 2025-07-15 江苏恒瑞医药股份有限公司 一种抗体药物偶联物的制备方法
IL299803A (en) * 2020-07-17 2023-03-01 Daiichi Sankyo Co Ltd Production method for antibody-drug conjugate
JP7848119B2 (ja) * 2020-07-20 2026-04-20 第一三共株式会社 抗her2抗体-薬物コンジュゲートとher二量体化阻害剤の組み合わせ
JP2023545096A (ja) * 2020-10-09 2023-10-26 アストラゼネカ ユーケー リミテッド 抗体-薬物コンジュゲート及びparp1選択的阻害薬の組み合わせ
AU2021378152A1 (en) * 2020-11-11 2023-06-22 Daiichi Sankyo Company, Limited COMBINATION OF AN ANTIBODY-DRUG CONJUGATE WITH ANTI-SIRPα ANTIBODY
CN116583526B (zh) * 2020-12-11 2025-09-26 微境生物医药科技(上海)有限公司 新型喜树碱衍生物、含其的组合物和其用途
US11806405B1 (en) 2021-07-19 2023-11-07 Zeno Management, Inc. Immunoconjugates and methods
TW202320858A (zh) 2021-07-19 2023-06-01 美商薩諾管理公司 免疫接合物及方法
KR20240099178A9 (ko) 2021-10-18 2025-12-10 다이이찌 산쿄 가부시키가이샤 항 cd37 항체-약물 콘주게이트
EP4514391A1 (en) * 2022-04-27 2025-03-05 Daiichi Sankyo Company, Limited Combination of antibody-drug conjugate with ezh1 and/or ezh2 inhibitor
CN119255825A (zh) * 2022-05-24 2025-01-03 第一三共株式会社 抗-cdh6抗体-药物缀合物的剂量方案
EP4737483A1 (en) 2023-06-30 2026-05-06 Daiichi Sankyo Company, Limited Antibody-drug conjugate production method including purification step using activated carbon material
WO2025054996A1 (en) * 2023-09-15 2025-03-20 Duality Biologics (Suzhou) Co., Ltd. Antibody-drug conjugate
WO2025260285A1 (en) * 2024-06-19 2025-12-26 Duality Biologics (Suzhou) Co., Ltd. Antibody drug conjugate
WO2025262130A1 (en) * 2024-06-19 2025-12-26 BioNTech SE Antibody drug conjugate

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CN104744560A (zh) * 2009-10-20 2015-07-01 Abbvie公司 使用蛋白a亲和色谱法分离和纯化抗-il-13抗体
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